MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUESPAN 0 DEGREE PLGA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 228160

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2024

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.H4; the date of manufacture was unknown.Udi: (b)(4).

Event Description

It was reported by the sales rep in switzerland that during a meniscal repair surgical procedure on (b)(6) 2024 the truespan 0 degree plga device had a knot was twisted while inserting the anchor.This blocked the triggering.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: the product was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned device.Visual inspection found that truespan 0 degree plga had the plates, and the suture still on the shaft near the needle, they were not deployed, also the red trigger was broken and completely loose.The shaft was deformed at the distal end.No other anomalies could be observed.The overall complaint was confirmed as the observed condition of the truespan 0 degree plga would contribute to the complained device issue.Based on the investigation findings, the potential cause could be traced to the procedural variables, such handling of the device or product interaction during procedure, when the needle was inside the joint and the needle tip was maneuver to desired location for optimal approximation, it was leveraged, therefore causing the damage to the needle and therefore the trigger was broken.As per ifu, it is necessary to use a calibrated probe, measure the width of the meniscal tissue to be repaired and set the adjustable depth.Also, it is important to fully squeeze the red deployment trigger while maintaining depth positioning to deliver the first implant.The implant is fully deployed when you hear an audible ¿click¿.Fully release the trigger after deployment, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: TRUESPAN 0 DEGREE PLGA
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 19125311
• MDR Text Key: 341298845
• Report Number: 1221934-2024-01224
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026036
• UDI-Public: 10886705026036
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228160
• Device Lot Number: 9L44079
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1